FDA.reportPublic FDA data

Breo

Primary DI
06975488665482
Brand
Breo
Company
Shenzhen Breo Technology Co., Ltd.
Model
Scalp 3L
Device description
Breo Laser Hair Growth Comb
Published
2025-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric
OAPLaser, Comb, Hair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
OAPLaser, Comb, HairPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242620000Breo Laser Hair Growth Comb (Scalp 3L)Shenzhen Breo Technology Co., Ltd.2024-11-01OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975488665482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975488665482069754886654826975488665482

GMDN Terms#

Term, Definition table
TermDefinition
Hair growth laser deviceAn electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529175390
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975488664256BreoN/A2024-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
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